Not yet recruitingNCT07859085ClinicalTrials.gov record

A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma

Colorectal Neoplasms · Pancreatic Ductal Adenocarcinoma

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 1
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 388 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). The study consists of a safety run-in period followed by a randomized/expansion period.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testing
Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

Exclusion Criteria:

Malabsorption syndrome or other conditions that would interfere with enteral absorption
Known and untreated, or active central nervous system (CNS) metastases
Known clinically significant liver disease
History of or active clinically significant cardiovascular dysfunction

Other protocol-defined inclusion/exclusion criteria may apply.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Group A: GDC-7035 + mFOLFOX6 + Panitumumab

Participants with CRC will receive GDC-7035 in combination with modified (levo)leucovorin, 5-fluorouracil (5-FU), oxaliplatin (mFOLFOX6) and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with mFOLFOX6 and panitumumab at doses determined to be safe in the safety run-in period.

Drug: GDC-7035 · Biological: Panitumumab · Drug: mFOLFOX6

Group B: GDC-7035 + FOLFIRI + Panitumumab

Participants with CRC will receive GDC-7035 in combination with leucovorin, 5-FU, irinotecan (FOLFIRI), and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with FOLFIRI and panitumumab at doses determined to be safe in the safety run-in period.

Drug: GDC-7035 · Biological: Panitumumab · Drug: FOLFIRI

Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 Monotherapy

Participants with PDAC will receive GDC-7035 in combination with modified leucovorin, 5-FU, irinotecan, oxaliplatin (mFOLFIRINOX) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with mFOLFIRINOX at doses determined to be safe in the safety run-in period.

Drug: GDC-7035 · Drug: mFOLFIRINOX

Group D: GDC-7035 + Gem-nabP or GDC-7035 Monotherapy

Participants with PDAC will receive GDC-7035 in combination with gemcitabine and nab-paclitaxel (Gem-nabP) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with Gem-nabP at doses determined to be safe in the safety run-in period.

Drug: GDC-7035 · Drug: Gem-nabP

GDC-7035 DRUG

Participants will receive GDC-7035 as per the schedule specified in the protocol.

Panitumumab BIOLOGICAL

Participants will receive panitumumab in accordance with the local prescribing information.

mFOLFOX6 DRUG

Participants will receive mFOLFOX6 in accordance with the local prescribing information.

FOLFIRI DRUG

Participants will receive FOLFIRI in accordance with the local prescribing information.

mFOLFIRINOX DRUG

Participants will receive mFOLFIRINOX in accordance with the local prescribing information.

Gem-nabP DRUG

Participants will receive Gem-nabP in accordance with the local prescribing information.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.